Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076811
Company: NATCO PHARMA USA
Company: NATCO PHARMA USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ANAGRELIDE HYDROCHLORIDE | ANAGRELIDE HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Discontinued | None | No | No |
ANAGRELIDE HYDROCHLORIDE | ANAGRELIDE HYDROCHLORIDE | EQ 1MG BASE | CAPSULE;ORAL | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
04/18/2005 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076811ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/13/2016 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
02/13/2013 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
08/31/2010 | SUPPL-5 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |